BEUDAMED
    Product Code: QJC FDA class 1 21 CFR 872.6855

    Plaque Disclosing Agent

    Dental

    The Plaque Disclosing Agent is a dental device intended to enhance visualization of the presence of plaque on tooth surfaces, helping patients and clinicians identify areas requiring improved oral hygiene. It is classified as FDA Class 1, subject to general controls and exempt from 510(k) premarket notification, regulated under 21 CFR 872.6855 within the Dental medical specialty. The product code is QJC. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QJC
    Device Class
    FDA class 1
    Regulation Number
    872.6855
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to enhance visualization of the presence of plaque on tooth surfaces.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K770990 DENTAL PLAQUE DISCLOSING AGENT

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.